FDA Orange Book · active-ingredient family
Fosaprepitant dimeglumine
Fosaprepitant dimeglumine: 4 brands, 18 generics; first approved Jan 25, 2008; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 18 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
4
Generics (ANDA)
18
Listed patents
2
Next patent expiry
Jan 11, 2039
in 12 yr 5 mo
Brand (NDA) products
Originator applications
- AVYXA HOLDINGSNDA 2204362026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL POWDER INTRAVENOUS Rx — - STERISCIENCENDA 2166862023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/50ML (EQ 3MG BASE/ML) SOLUTION INTRAVENOUS Rx — - EMENDRLDMERCK AND CO INCNDA 02202320082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 115MG BASE/VIAL POWDER INTRAVENOUS Discontinued — EQ 150MG BASE/VIAL POWDER INTRAVENOUS Rx AP - FOSAPREPITANT DIMEGLUMINETEVA PHARMS USANDA 2100642019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL POWDER INTRAVENOUS Rx —
Generic (ANDA) products (18)
Abbreviated applications
- FOSAPREPITANT DIMEGLUMINEPIRAMAL CRITICALANDA 2146832023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL POWDER INTRAVENOUS Discontinued — - FOSAPREPITANT DIMEGLUMINEPRAXGENANDA 2131992021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL POWDER INTRAVENOUS Discontinued — - FOSAPREPITANT DIMEGLUMINEASPIROANDA 2146162021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL POWDER INTRAVENOUS Rx AP - FOSAPREPITANT DIMEGLUMINECHIA TAI TIANQINGANDA 2121432021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL POWDER INTRAVENOUS Rx AP - FOSAPREPITANT DIMEGLUMINEEUGIA PHARMAANDA 2106252021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL POWDER INTRAVENOUS Rx AP - FOSAPREPITANT DIMEGLUMINEDR REDDYSANDA 2111602020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL POWDER INTRAVENOUS Rx AP - FOSAPREPITANT DIMEGLUMINECAPLINANDA 2039392020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL POWDER INTRAVENOUS Discontinued — - FOSAPREPITANT DIMEGLUMINEQILU PHARM HAINANANDA 2131062020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL POWDER INTRAVENOUS Rx AP - FOSAPREPITANT DIMEGLUMINEACCORD HLTHCAREANDA 2040252020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL POWDER INTRAVENOUS Discontinued — - FOSAPREPITANT DIMEGLUMINECHARTWELL RXANDA 2129572020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL POWDER INTRAVENOUS Discontinued — - FOSAPREPITANT DIMEGLUMINEAPOTEXANDA 2050202019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL POWDER INTRAVENOUS Discontinued — - FOSAPREPITANT DIMEGLUMINEBAXTER HLTHCARE CORPANDA 2118602019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL POWDER INTRAVENOUS Discontinued — - FOSAPREPITANT DIMEGLUMINEBE PHARMSANDA 2123092019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL POWDER INTRAVENOUS Rx AP - FOSAPREPITANT DIMEGLUMINEGENEYORK PHARMSANDA 2116242019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL POWDER INTRAVENOUS Discontinued — - FOSAPREPITANT DIMEGLUMINELUPINANDA 2106892019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL POWDER INTRAVENOUS Discontinued — - FOSAPREPITANT DIMEGLUMINEMSNANDA 2099652019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL POWDER INTRAVENOUS Rx AP - FOSAPREPITANT DIMEGLUMINEMYLAN LABS LTDANDA 20401520192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 115MG BASE/VIAL POWDER INTRAVENOUS Discontinued — EQ 150MG BASE/VIAL POWDER INTRAVENOUS Rx AP - FOSAPREPITANT DIMEGLUMINEFRESENIUS KABI USAANDA 2061972016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 150MG BASE/VIAL POWDER INTRAVENOUS Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 12042504 | in 12 yr 5 mo | Product | |
| 11065265 | in 12 yr 5 mo | Product |
Approval history
FDA approval span
First approval
19 yr ago
Most recent approval
4 mo ago
Approvals span 2008–2026 across 22 FDA applications.
Brand (NDA) 418%
Generic (ANDA) 1882%
Fosaprepitant dimeglumine: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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